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Comparison of Translocator Protein Expression and Binding Activity in Normal Tissue Versus Non Melanotic Malignancy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01265472
First received: December 22, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose
Translocator protein (TSPO) is a intracellular protein that is found primarily in the outer membrane of the mitochondria that is encoded by the TSPO gene. It has been found that TSPO expression in the skin correlates with cell proliferation and differentiation. Many studies have shown that TSPO overexpression in solid malignancies such as in ovarian cancer, colon cancer, and others, was also found to correlate with more aggressive cancer behavior. Working Hypothesis and Aims: Previous studies described an aberrant expression of TSPO levels in solid malignancies as compared to normal tissues. It is assumed that this aberration can be found in cuntaneous malignancies as well. The occurrence of this aberration may lead to the understanding of the mechanism of TSPO involment in the cutaneous malignancy, and in malignancies in general. Methods: The study will be carried out on surgically resected skin lesions suspected to SCC or BCC, which will be removed as part of the surgical routine treatment. The excision will be made in elliptic shape including the lesion and a part of normal skin surrounding it. A sample will be taken from the central part of the lesion and from the external extremity of the normal tissue. Western Blot will be conducted to detect the expression of TSPO. Binding activity with the TSPO specific ligandwill also be determined. Expected Results: We expect to observe either (a) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue or (b) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue. Importance: Until today, only a very small number of studies have examined TSPO in cutaneous malignancies, and these only examined TSPO expression. Our study will also measure the binding activity of TSPO in cutaneous malignant tissues compared to normal tissues

Condition
Squamous Cell Carcinoma
Basal Cell Carcinoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of the Expression Level of Translocator Protein (TSPO) and Binding Activity in Normal Cutaneous Tissue Versus Non Melanotic Cutaneous Malignancy.

Further study details as provided by Rambam Health Care Campus:

Biospecimen Retention:   Samples Without DNA
Specimens of normal skin, squamous cell carcinoma or basal cell carcinoma

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Not an observational study.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Basal Cell Carcinoma or Squamous Cell Carcinoma

Exclusion Criteria:

  • Non-compliance with inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Prof. Rafael Nagler, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01265472     History of Changes
Other Study ID Numbers: RMB455-CTIL 
Study First Received: December 22, 2010
Last Updated: December 22, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Translocator Protein
Basal Cell Carcinoma
Squamous Cell Carcinoma
Malignancy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on December 02, 2016